Quality Assurance Associate – Manufacturing Floor (Evening & Night Shift)
Elanco
June 30, 2026
On-site
Elwood, KS
Operations
Your Role: Quality Assurance Associate – Manufacturing Floor
Responsibilities:
- Coordinate Quality Assurance Department activities for manufacturing floor support; provide quality floor support by observing daily processes for statuses, issues/concerns, and issuance of cell banks.
- Act as first responder for manufacturing activities and represent QA on cross-functional process teams.
- Identify, investigate, and resolve complex technical issues; participate in investigation teams, determine next steps, and support proper closeout and follow-up actions; make independent decisions and notify management.
- Perform QA review/approval of controlled documents (e.g., solution records, batch records, logbooks, autoclave cycles) with strong attention to detail.
- Review change management documentation, deviations, investigations, and CAPA records for completion; write new QA documents and revise existing ones as needed.
- Participate and manage QA projects with minimal supervision; assist QA Associate(s) and QA Manager(s) as needed.
Minimum Qualifications:
- BA/BS (or Master’s) in Life Science discipline preferred, and/or 3 years’ experience in a regulated industry (USDA, FDA, ISO, etc.).
- Direct Quality Assurance experience within regulated industry.
- Comprehensive knowledge of quality and GMP principles; current understanding of global GMP drug manufacturing regulations.
- Ability to work in controlled/clean room environments requiring gowning qualifications.
Preferred Qualifications:
- Basic statistics; documentation review/approval; risk tools; technical writing; writing/reviewing/approving investigations.
- Ability to handle multiple tasks and competing priorities.
- Strong interpersonal skills; effective team collaboration.
- Demonstrated ability to make sound independent decisions.
Benefits:
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.
Application/Work Schedule Information:
- Location: Elwood, KS Manufacturing Site.
- Evening shift: 4:00pm–12:30am; Night shift: 12:00am–8:30am, Mon–Fri; rotating weekends (every 3rd weekend), 24/7 site.
Responsibilities:
- Coordinate Quality Assurance Department activities for manufacturing floor support; provide quality floor support by observing daily processes for statuses, issues/concerns, and issuance of cell banks.
- Act as first responder for manufacturing activities and represent QA on cross-functional process teams.
- Identify, investigate, and resolve complex technical issues; participate in investigation teams, determine next steps, and support proper closeout and follow-up actions; make independent decisions and notify management.
- Perform QA review/approval of controlled documents (e.g., solution records, batch records, logbooks, autoclave cycles) with strong attention to detail.
- Review change management documentation, deviations, investigations, and CAPA records for completion; write new QA documents and revise existing ones as needed.
- Participate and manage QA projects with minimal supervision; assist QA Associate(s) and QA Manager(s) as needed.
Minimum Qualifications:
- BA/BS (or Master’s) in Life Science discipline preferred, and/or 3 years’ experience in a regulated industry (USDA, FDA, ISO, etc.).
- Direct Quality Assurance experience within regulated industry.
- Comprehensive knowledge of quality and GMP principles; current understanding of global GMP drug manufacturing regulations.
- Ability to work in controlled/clean room environments requiring gowning qualifications.
Preferred Qualifications:
- Basic statistics; documentation review/approval; risk tools; technical writing; writing/reviewing/approving investigations.
- Ability to handle multiple tasks and competing priorities.
- Strong interpersonal skills; effective team collaboration.
- Demonstrated ability to make sound independent decisions.
Benefits:
- Multiple relocation packages; 8-week parental leave; 9 Employee Resource Groups; annual bonus; up to 6% 401K matching.
Application/Work Schedule Information:
- Location: Elwood, KS Manufacturing Site.
- Evening shift: 4:00pm–12:30am; Night shift: 12:00am–8:30am, Mon–Fri; rotating weekends (every 3rd weekend), 24/7 site.